Gaps That Need Filling in IVD Instrument Development

By MedTech Outlook | Tuesday, January 12, 2021

From concept, design, production, and production through manufacturing, post-market support, and end-of-life management, it is essential to choose an OEM partner with the expertise to understand the whole product life cycle.

FREMONT, CA: The In-Vitro Diagnostics (IVD) market for medical devices is fast-paced and extremely competitive, with innovative and advanced technologies emerging every day. High technological risks, cost overruns, time delays, and missing end-user deadlines are just some of the pitfalls that might derail a project or lead to an unfinished product. Besides, the skill criteria and regulatory environment for IVD medical devices continue to escalate in scope, rendering it much more difficult for a diagnostic organization to keep track and put its platform products on the market promptly and with sufficient processes in place to serve the consumer ultimately.

A comprehensive approach is required to define holes and de-risk the whole production process from start to finish.

Gaps that Require Filling

Lack of internal infrastructure or experience will make it hard to create and execute a well-integrated framework for IVD product creation. In some situations, the resources required may be present in the business but are not accessible because they are committed to other vital projects. There could be insidious technology gaps, efficiency limits, or specification flaws that may compromise the project if not detected early on in other situations. Moreover, there could also be a shortage of specialized skills. For example, compliance skills, competence in operating quality systems, and the ability to identify procedures are all important when operating with or producing items intended for a controlled environment.

Internal and external partnerships are also crucial to closing these holes. That is why many businesses are exploring Original Equipment Manufacturer (OEM) collaborations today. It is crucial to find an OEM partner who provides expertise in the production process. From concept, design, production, and production through manufacturing, post-market support, and end-of-life management, it is essential to choose an OEM partner with the expertise to understand the whole product life cycle. This aspect involves understanding the IVD solution's end-to-end regulatory, quality, and service requirements.

Under the OEM collaboration setting, both parties should take the time to consider the principles that each partner brings to the project to get the best out of the concept team that would usually work closely to create an excellent long-term relationship.